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Trials ; 25(1): 512, 2024 Jul 29.
Artigo em Inglês | MEDLINE | ID: mdl-39075587

RESUMO

BACKGROUND: In the treatment of advanced pancreatic cancer, chemotherapy plays a pivotal role. Despite its effectiveness, this regimen is often marred by side effects such as anemia, neuropathy, fatigue, nausea, and malnutrition, which significantly affect patients' tolerance to the treatment. Some studies have shown that vitamin C could potentially augment chemotherapy's tolerability, notably by boosting iron absorption, ameliorating anemia, and relieving pain and numbness in hands and feet. Nevertheless, the integration of vitamin C with chemotherapy to mitigate toxic side effects and enhance the quality of life for advanced pancreatic cancer patients has not been examined in any randomized controlled trials to date. METHODS: A prospective, single-center, open-label, randomized controlled trial will be conducted at Fudan University Shanghai Cancer Center from September 2023 to September 2026. A total of at least 100 patients with advanced pancreatic adenocarcinoma exhibiting distant metastases will be recruited and randomly assigned to the chemotherapy group or the chemotherapy plus vitamin C group. The primary endpoint is the rate of anemia. Secondary endpoints include the rate of grade 3 neuropathy, change of numeric rating scale, quality of life, and overall survival. DISCUSSION: This study aims to assess the impact of low-dose vitamin C on enhancing the quality of life for patients with metastatic pancreatic cancer undergoing gemcitabine and nab-paclitaxel chemotherapy. TRIAL REGISTRATION: The trial was registered with the ClinicalTrials.gov (NCT06018883) on August 31, 2023.


Assuntos
Anemia , Protocolos de Quimioterapia Combinada Antineoplásica , Ácido Ascórbico , Neoplasias Pancreáticas , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Humanos , Neoplasias Pancreáticas/tratamento farmacológico , Neoplasias Pancreáticas/mortalidade , Ácido Ascórbico/uso terapêutico , Ácido Ascórbico/efeitos adversos , Ácido Ascórbico/administração & dosagem , Anemia/tratamento farmacológico , Estudos Prospectivos , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Gencitabina , Desoxicitidina/análogos & derivados , Desoxicitidina/efeitos adversos , Desoxicitidina/uso terapêutico , Desoxicitidina/administração & dosagem , Paclitaxel/efeitos adversos , Paclitaxel/administração & dosagem , Resultado do Tratamento , China , Pessoa de Meia-Idade , Albuminas/efeitos adversos , Albuminas/administração & dosagem , Albuminas/uso terapêutico , Masculino , Feminino , Adulto
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